Effect of Vitamin D Supplementation on Overactive Bladder and Urinary Incontinence Symptoms in Older Men: Ancillary Findings From a Randomized Trial.

PURPOSE: Our goal was to evaluate vitamin D supplementation for preventing or treating overactive bladder and urinary incontinence in men. MATERIALS AND METHODS: Ancillary study of men aged ≥55 years in VITAL (VITamin D and OmegA-3 TriaL). Randomized treatments included: vitamin D3 (cholecalciferol), marine omega-3 fatty acids, or matching placebo. Structured urinary incontinence questions measured the prevalence of overactive bladder at year 5 and urinary incontinence at years 2 and 5, along with incidence and progression of urinary incontinence from years 2 to 5. Prespecified subgroup analyses examined men with low baseline serum 25-hydroxyvitamin D (<20 ng/mL). RESULTS: Among the 11,486 men who provided data at year 2 and 10,474 at year 5, mean age was 68 years at year 2, with 23% racial/ethnic minorities. In primary analyses, vitamin D supplementation compared to placebo did not lower odds of overactive bladder at year 5 (OR 0.97, 95% CI 0.87-1.08) or weekly urinary incontinence at year 2 (OR 0.94, 95% CI 0.83-1.05) or year 5 (OR 0.98, 95% CI 0.88-1.09). We found interactions of baseline serum 25-hydroxyvitamin D level with vitamin D supplementation for overactive bladder (P value for interaction = .001), and secondarily, for any urinary incontinence at year 2 (P value for interaction = .05). Men with baseline 25-hydroxyvitamin D <20 ng/mL, who were assigned to vitamin D supplements, had lower odds of overactive bladder (OR 0.51, 95% CI 0.35-0.76) compared to placebo, yet higher odds of any urinary incontinence (OR 1.24, 95% CI 0.93-1.64). CONCLUSIONS: Overall, vitamin D supplementation did not improve overactive bladder or urinary incontinence compared to placebo. However, specific use of vitamin D in men with lower 25-hydroxyvitamin D levels had inconsistent findings.

Vitamin D supplements and prevalent overactive bladder in women from midlife through older ages.

OBJECTIVE: The objective of this study is to determine if vitamin D supplementation is associated with prevalent overactive bladder (OAB) in women across the aging spectrum. METHODS: We used the Nurses' Health Study (NHS) I (initiated in 1976) and NHS II (initiated in 1989) cohorts to evaluate the association of vitamin D supplements with prevalent OAB, all of which were reported by participants in 2019 in both NHS cohorts. OAB was defined as the self-reported need to rush to toilet to urinate at least sometimes. Further, OAB/wet included incontinence at least monthly because of urgency, whereas OAB/dry included incontinence once per month or less, or stress-predominant incontinence. Multivariable-adjusted odds ratios and 95% confidence intervals of OAB/dry and OAB/wet subtypes were estimated using logistic regression models. RESULTS: Among the 75,316 women (age range, 55-98 y) from NHS and NHS II OAB prevalence was 26%. Increasing prevalence was observed across each older age group, with 41% of women 85 years or older reporting OAB symptoms. OAB/dry was more common (18%) than OAB/wet (8%). After multivariable adjustment, no clinically significant association between vitamin D supplementation and prevalent OAB or OAB type was observed. CONCLUSIONS: OAB symptoms are highly prevalent across adult women, including the oldest old, who are often excluded from treatment trials. Despite interest in vitamin D supplementation as a low-cost strategy to address OAB, our findings indicate oral vitamin D is not associated with prevalent OAB in middle-aged and older women.

The relationship between bladder storage function and frequent micturition after TURP.

PURPOSE: To investigate the relationship between preoperative bladder function and frequent micturition after transurethral resection of prostate in patients with benign prostatic hyperplasia. METHODS: We retrospectively included 80 eligible patients aged 54-87 years (mean age 69.8 years) who underwent transurethral resection of the prostate at our hospital from January 2019 to October 2021. Patients were divided into detrusor overactivity positive and negative groups, and according to bladder compliance, they were divided into: low (G1), normal (G2), and high (G3) bladder compliance groups. RESULTS: The incidence and score of postoperative frequent micturition in the detrusor overactivity positive group were higher than those in the detrusor overactivity negative group. The incidence and score of postoperative frequent micturition in the low bladder compliance group were higher than those in the normal and high bladder compliance groups. There was no significant difference in the score of frequent micturition between the normal and high bladder compliance groups. Multivariate logistic regression analysis indicated that frequent micturition was significantly correlated with detrusor overactivity, bladder compliance, maximum cystometric capacity, and maximum flow rate. CONCLUSION: This study confirmed that patients with abnormal bladder storage functions (detrusor instability and low bladder compliance) before transurethral resection of the prostate were likely to have frequent and severe urination after transurethral resection of the prostate. Therefore, preoperative urodynamic examination to evaluate the urinary storage function of patients with benign prostatic hyperplasia is of great significance to predict the occurrence and degree of postoperative frequent micturition.

Real-world Compliance With Percutaneous Tibial Nerve Stimulation Maintenance Therapy in an American Population.

OBJECTIVE: To evaluate percutaneous tibial nerve stimulation (PTNS) maintenance therapy dropout rates and identify factors associated with compliance in an American population. METHODS: We retrospectively queried our PTNS database for patients from 2014-2019. Demographic, relevant clinical, and visit data were collected. Maintenance therapy was patient-driven and frequency of sessions was tapered based on symptomology. Upon completion of 12 initial sessions, we assessed dropout from maintenance at 3, 6, 9, and 12 months. Multiple variables were tested for correlation with dropout in patients continuing maintenance therapy for 1 year vs those who dropped out. RESULTS: One hundred and sixty-three PTNS patients were identified, of which 104 completed initial therapy and 81 proceeded with maintenance therapy. At 3, 6, 9, and 12 months, maintenance continuation rates were 77.8% (63/81), 58.0% (47/81), 45.6% (37/81), and 39.5% (32/41), respectively. Primary reasons for dropout were worsening of urinary symptoms/lack of efficacy (n = 21), time commitment (n = 9), loss of insurance (n = 5), medical comorbidities (n = 4), request for alternative OAB treatment (n = 2), and unknown (n = 8). On both univariate and multivariate analysis, perceived symptom improvement (P<.01; HR = 0.02, P< .01) was associated with continuing maintenance therapy. On only univariate analysis, neurological history (P = .02) and multiple sclerosis history (0.02) were associated with continuing therapy. CONCLUSION: Only 39.5% of patients continue to undergo maintenance PTNS therapy after 1 year. Future studies are required to understand and ameliorate factors for low compliance in PTNS maintenance therapy.

Factors Associated With Long-Term Use of Percutaneous Tibial Nerve Stimulation for Management of Overactive Bladder Syndrome.

OBJECTIVES: The aims of the study were to estimate the rate of percutaneous tibial nerve stimulation maintenance therapy (PTNS-MT) among women with overactive bladder syndrome (OAB) and evaluate factors associated with long-term use of PTNS. METHODS: Patients who completed 12 weekly sessions of PTNS (PTNS-IN) for OAB between 2009 and 2016 within the Kaiser Permanente Northern California were identified using Current Procedural Terminology and International Classification of Diseases codes. Bivariate analysis was performed to compare demographic and clinical variables. A logistic regression model was used to determine factors associated with PTNS-MT compared with the use of alternative treatments following PTNS-IN. RESULTS: Of the 1331 patients who initiated PTNS for OAB, 347 (26%) completed PTNS-IN. Of these, 46% (n = 158) continued with long-term PTNS therapy, defined as completion of at least 8 additional PTNS sessions for a 32-week period. On bivariate analysis, those choosing PTNS-MT were more likely to be white (88%, P < 0.0001), nondiabetic (89%, P = 0.03), did not use anticholinergics before PTNS initiation (41%, P = 0.04), and had no prior surgery for stress incontinence (SUI; 84%, P = 0.01). In multivariable analysis, race was a significant factor with black, Hispanic, and Asian women less likely to continue with PTNS-MT. Women with prior use of first-line OAB therapy were 78% more likely to undergo PTNS-MT. Women with prior surgery for SUI were 53% less likely to continue PTNS-MT. CONCLUSIONS: Almost half of patients who completed PTNS-IN continued with PTNS-MT. White race, prior use of first-line OAB therapy, and no prior surgery for SUI were associated with long-term therapy.

Overactive bladder in an integrated delivery system: a longitudinal cohort study.

BACKGROUND: Overactive bladder (OAB) is common and morbid. Medication and diagnosis claims may be specific, but lack sensitivity to identify patients with overactive bladder. We used an "electronic health record (EHR) phenotype" to identify cases and describe treatment choices and anticholinergic burden for OAB. METHODS: We conducted a retrospective cohort study in a large, integrated health delivery system between July 2011 and June 2012 (2-year follow-up). We examined care from primary care and specialty clinics, medication and procedure use, and anticholinergic burden for each patient. RESULTS: There were 7362 patients with an EHR OAB phenotype; 50% of patients were > 65 years old, 74% were female, and 83% were white. The distribution of care included primary care physician (PCP)/specialty co-management (25% of patients); PCP care only (18%); urology only (13%); or some other combination of specialty care (33%). Only 40% of patients were prescribed at least 1 OAB medication during the study. The mean duration of prescribed medication was 1.5 months (95% confidence interval [CI], 1.4 to 1.6 months; range, < 1 month to 24 months). Independent predictors of receipt of an OAB medication included increasing age (odds ratio [OR], 1.4 for every 10 years; 95% CI, 1.4 to 1.5), women (OR, 1.6 compared with men; 95% CI, 1.4 to 1.8), diabetes (OR, 1.3; 95% CI, 1.1 to 1.5), and certain sources of care compared with PCP-only care: PCP/specialty co-management (OR, 1.8; 95% CI, 1.5 to 2.0), urology (OR, 2.2; 95% CI, 1.8 to 2.6), and multiple specialists (OR, 1.4; 95% CI, 1.2 to 1.8). Very few patients received other treatments: biofeedback (< 1%), onabotulinumtoxinA (2%), or sacral nerve stimulation (1%). Patients who received OAB medications had significantly higher anticholinergic burden than patients who did not (anticholinergic total standardized daily dose, 125 versus 46; P < .001). CONCLUSIONS: Although OAB is common and morbid, in a longitudinal study using an EHR OAB phenotype 40% of patients were treated with OAB medication and only briefly.

Racial and Socioeconomic Factors Influence Utilization of Advanced Therapies in Commercially Insured OAB Patients: An Analysis of Over 800,000 OAB Patients.

OBJECTIVE: To determine if racial and/or socioeconomic factors influence advanced therapy utilization for refractory overactive bladder (OAB) among the commercially insured. METHODS: We queried Optum, a national claims database, between 2003 and 2017. Non-neurogenic OAB patients were identified using ICD-9/10 diagnosis codes. Demographic and treatment data were collected, including oral medication therapies (anticholinergic, beta3 agonists), and advanced therapies (OnabotulinumtoxinA [BTX], Sacral Nerve Stimulation [SNS], percutaneous tibial nerve stimulation [PTNS]). Associations between patient sociodemographic factors and advanced therapy utilization were explored. RESULTS: Of 4,229,617 OAB patients, 807,612 (19%) received medical therapies, of which 95% received oral medications only and only 4.7% received advanced therapies. Asians had the lowest use of oral therapy use (14% vs 18%-19% in other races/ethnicities, P <0.05), and advanced therapy use (0.44% vs 0.71%-0.93%, P <0.05). Asians and Hispanics were least likely to utilize SNS therapy and most likely to use PTNS compared to Blacks and Whites. BTX use was similar between races/ethnicities (P <0.05). Female gender (OR 1.65 [CI 1.61,1.69]), younger age (<65) (OR 1.28 [1.25,1.31]), higher annual income ≥$40K (OR 1.09 [1.06,1.12]) and prior use of oral medications (OR 3.30 [3.21,3.38] for 1 medication) were significantly associated with receiving advanced therapies. Non-white race (OR 0.89 [0.87,0.91]), lower education level (less than a bachelor's degree) (OR 0.97 [0.94,0.99]), and Northeast region were associated with a lower likelihood of receiving advanced therapies (P <0.05 for all). CONCLUSION: Among commercially insured, racial and socioeconomic factors predict utilization of advanced OAB therapies, including race/ethnicity, age, gender, education level, and region.

Practice Patterns for Women With Overactive Bladder Syndrome: Time Between Medications and Third-Line Treatments.

OBJECTIVE: The aims of this study are to determine how long it takes female patients with overactive bladder (OAB) to receive third-line treatment after starting OAB medications and identify factors associated with increased time. METHODS: This was a retrospective observational cohort study of adult female patients with OAB who received third-line treatment between 2013 and 2015 using insurance claims databases. Primary outcome was time between first OAB medication and first third-line treatment. Additional variables were patient demographics, diagnostic tests, and medical comorbidities. RESULTS: Of 3232 patients included in this study, 48.8% underwent sacral neuromodulation, 31.6% percutaneous tibial nerve stimulation, and 23% intradetrusor onabotulinumtoxin A injections. Twenty-one percent of patients filled medication prescriptions for 3 or more antimuscarinic medications, 30.4% took mirabegron, and 32.3% had advanced diagnostic tests suggestive of a specialist evaluation prior to starting medications. Median time to third-line treatment was 37.7 (interquartile range, 14.9, 16.3) months. Adjusted linear regression model revealed 2 predominant predictors of time to third-line treatments: each antimuscarinic medication trial was associated with 5.3 (95% confidence interval, 4.4-6.3) more months before third-line treatment (P < 0.001), and advanced diagnostic evaluations prior to starting medications were associated with 28.2 (95% confidence interval, 21-35) fewer months before third-line treatment (P < 0.001). CONCLUSIONS: Women with OAB who undergo third-line therapy do so on average more than 3 years after starting medications. Time to third-line treatment is largely driven by the number of antimuscarinic medications tried and timing of diagnostic evaluation by a specialist. Based on these results, we suggest providers consider limiting antimuscarinic trials to 2 medications prior to moving on to other treatment options.

Statewide Success of Staged Sacral Neuromodulation for the Treatment of Urinary Complaints in California (2005-2011).

PURPOSE: Sacral neuromodulation (SNS) is approved by the Food and Drug Administration as a third-line treatment for refractory overactive bladder, idiopathic urinary retention, and fecal incontinence. Prior to implantation of an implantable pulse generator, all patients undergo a trial phase to ensure symptom improvement. The published success rates of progression from the test phase to permanent implant vary widely (range, 24% to >90%). We sought to characterize success rates using a statewide registry. METHODS: Using nonpublic data, we identified SNS procedures using the California Office of Statewide Planning and Development ambulatory surgery database from 2005 to 2011. A successful trial was defined as receiving a stage 2 generator implantation after trial lead placement. Multivariable logistic regression was performed to identify factors associated with staged success. RESULTS: During the study period, 1396 patients underwent a staged SNS procedure, with 962 (69%) subsequently undergoing generator placement. Successful trial rates were 72% for overactive bladder wet, 69% for urgency/frequency, 68% for interstitial cystitis, 67% for neurogenic bladder, and 57% for urinary retention. On multivariate logistic regression, only male sex (odds ratio, 0.51) and urinary retention [odds ratio, 0.54) were significantly associated with lower odds of success, whereas age, race/ethnicity, medical insurance, and placement at an academic or high-volume institution had no association. CONCLUSIONS: The "real world" success rates for staged SNS implantation in California are less than those observed by some academic centers of excellence but better than previously reported for Medicare beneficiaries. Successful trial rates for interstitial cystitis and neurogenic voiding dysfunction are similar to refractory overactive bladder.

Overactive bladder and bladder pain syndrome/interstitial cystitis in primary Sjögren's syndrome patients: A nationwide population-based study.

To investigate the risks of overactive bladder (OAB) and bladder pain syndrome/interstitial cystitis (BPS/IC) in primary Sjögren's syndrome (pSS) patients. A nationwide, population-based cohort study was conducted using data from Taiwan's National Health Insurance Research Database. From 2001 to 2010, participants with newly diagnosed pSS were recognized as the study group. In addition, a comparison cohort of non-pSS participants was matched for age, gender, and initial diagnosis date. Risks of developing OAB and BPS/IC in pSS patients of different age, sex, and various therapeutic strategies were calculated. Hazard ratios (HR) and a 95% confidence interval (CI) were analyzed by Cox proportional hazard model. In total, 11,526 pSS patients were recognized. The HRs of OAB and BPS/IC in pSS patients were 1.68 (95% C.I.: 1.48-1.91, p<0.01) and 2.34 (95% C.I.: 1.59-3.44, p<0.01), respectively. The risks of OAB and BPS/IC were significantly increased for pSS patients aged < 65 years (HR: 1.73 and 2.67), female patients (HR: 1.74 and 2.34), and patients requiring treatment for dry eyes and dry mouth (HR: 2.06 and 2.93). pSS patients exhibited an increased risk of OAB and BPS/IC. Female gender, younger age, and severe glandular dysfunction requiring treatments were potential risk factors.

Coffee intake, health-related quality of life, and associated factors of overactive bladder in older Korean women living in rural South Korea.

Overactive bladder (OAB) is a common health problem in older women. The aim of the study was to investigate coffee consumption, health-related quality of life (HRQOL), and associated factors of OAB in older Korean women living in rural South Korea. A total of 248 women aged 65 years and older participated in this study. Chi-square tests, t-tests, and multivariable logistic regressions were performed. The means of coffee consumption between OAB and non-OAB groups were not significantly different. Women with OAB showed significantly lower HRQOL than women with stress urinary incontinence only. OAB was associated with high body mass index and poor health status.

Management of Idiopathic Overactive Bladder Syndrome: What Is the Optimal Strategy After Failure of Conservative Treatment?

CONTEXT: A considerable number of patients affected by the overactive bladder syndrome (OAB) do not respond to pharmacotherapy and bladder training due to unsatisfactory response or intolerability. OBJECTIVE: To review the available literature assessing therapeutic effect of the available third-line treatment modalities for OAB. EVIDENCE ACQUISITION: PubMed, Medline, and Cochrane databases were searched for all studies comparing outcomes of the available third-line treatment modalities for OAB. EVIDENCE SYNTHESIS: Several minimally invasive surgical procedures are available for patients with refractory OAB. These therapies include intravesical botulinum toxin type A, posterior tibial nerve stimulation, and sacral neuromodulation. CONCLUSIONS: None of the mentioned therapeutic modalities shows strong superiority over another. If the results of one therapy are not satisfactory, switching to another third-line treatment can be attempted. The treatment algorithm is dependent on several factors, including age, comorbidity, patient preference, surgical expertise, and financial concerns. All these factors should be taken into consideration before initiation of treatment. PATIENT SUMMARY: In the management of drug-resistant overactive bladder syndrome, the different minimally invasive treatments that are available are equal. If the results of one therapy are not satisfactory, switching to another treatment can be attempted. The treatment algorithm is dependent on several factors, including age, comorbidity, patient preference, surgical expertise, and financial concerns.

Primary Nonadherence to Overactive Bladder Medications in an Integrated Managed Care Health Care System.

BACKGROUND: Treatment for overactive bladder (OAB) remains suboptimal, in part because of patient nonadherence to medications. Primary nonadherence is when patients fail to pick up their initial prescriptions. OBJECTIVE: To measure primary nonadherence to OAB medications within 30 days of a first OAB prescription order using electronic medical records from a U.S. managed care health care system METHODS: A retrospective cohort study was conducted using electronic medical records from the Kaiser Permanente Southern California (KPSC) database to identify patients with new OAB prescriptions between January 1, 2007, and December 31, 2013. The index date was defined as the first order of an OAB prescription. Patients had to be aged ≥ 18 years on the index date and were required to have 12 months of continuous membership with drug benefit eligibility before, during, and after the index date. Patients were defined as primary nonadherent if they did not pick up their new OAB prescriptions within 30 days of the order date. Descriptive statistics and a multivariable logistic regression analysis with backward selection were conducted to identify factors associated with patients who were primary nonadherent versus adherent. RESULTS: There were 9,050 patients with a new OAB prescription order; 1,662 (18%) of these were primary nonadherent. Patients with primary nonadherence were younger in age (56.9 [SD ± 16.0] years vs. 63.9 [SD ± 14.8] years; P < 0.001) and more likely to have commercial insurance (65.9% vs. 46.2%; P < 0.001). They also had lower mean Charlson Comorbidity Index (CCI) scores (1.99 vs. 2.70; P < 0.001), fewer OAB-related comorbidities, fewer concomitant medications (P < 0.005), and fewer overall prescriptions dispensed in the previous 12 months (P < 0.001) compared with adherent patients. Significant factors such as commercial insurance (P = 0.013), race other than white (P = 0.020), CCI = 0 versus CCI ≥ 2 (P = 0.001), urinary tract infections (P < 0.001), and falls (P = 0.047) were associated with a higher likelihood of primary nonadherence versus adherence. CONCLUSIONS: Nearly 1 in 5 patients did not pick up their new OAB medications within 30 days of the order date. Knowledge of factors associated with primary nonadherence may inform strategies for improving management of OAB. DISCLOSURES: This study was supported by a research grant provided by Astellas Pharma Global Development. Rashid and Lin do not have any financial interests or potential conflict of interest with regard to the work. Vassilakis, Kristy, and Ng were employees of Astellas Pharma Global Development when this study was conducted. Study concept and design were contributed by Rashid and Ng, along with the other authors. Rashid and Lin collected the data, and data interpretation was performed by Rashid, Ng, and Lin, along with Vassilakis and Kristy. The manuscript was written by Rashid and Ng, along with Vassilakis and Lin, and revised by Rashid, Ng, and Lin.

Estimated Budget Impact of Increased Use of Mirabegron, A Novel Treatment for Overactive Bladder.

BACKGROUND: Oral pharmacological treatment for overactive bladder (OAB) consists of antimuscarinics and the beta-3 adrenergic agonist mirabegron. Antimuscarinic adverse events (AEs) such as dry mouth, constipation, and blurry vision can result in frequent treatment discontinuation rates, leaving part of the OAB population untreated. Antimuscarinics also contribute to a patient's anticholinergic cognitive burden (ACB), so the Beers Criteria recommends cautious use of antimuscarinics in elderly patients who take multiple anticholinergic medications or have cognitive impairment. Since mirabegron does not affect the cholinergic pathways, it is unlikely to contribute to a patient's ACB. OBJECTIVE: To estimate the health care costs associated with the pharmacological treatment of OAB with mirabegron and antimuscarinics from U.S. commercial payer and Medicare Advantage perspectives, using a budget impact model. METHODS: For this budget impact model, 2 analyses were performed. The primary analysis estimated the budgetary impact of increasing the use of mirabegron in a closed patient cohort treated with oral pharmacological treatments. The secondary analysis modeled the economic impact in an open cohort by allowing untreated patients to begin treatment with mirabegron after potential contraindication, intolerance, or lack of effectiveness of antimuscarinics. The analyses were performed over a 3-year time horizon. The economic impact of increased mirabegron use was quantified using direct medical costs, including prescription costs and health resource utilization (HRU) costs. Costs of comorbidities included pharmacy and medical costs of treating OAB-related urinary tract infections (UTI), skin rashes, and depression. An analysis of a large single-site integrated health network database was commissioned to quantify ACB-related HRU in terms of the increases in yearly outpatient and emergency department visits. Based on this analysis, the model associated each unit increase in ACB score with increased HRU and probability of mild cognitive impairment. Clinical outcomes of increased use of mirabegron were presented as the number of AEs and comorbidity episodes that could be avoided. One-way sensitivity analyses were performed to quantify the expected budget impact over the range of uncertainty for the key input variables. RESULTS: Primary analysis calculated the impact of increasing the use of mirabegron from 4.5% to 5.3%, 7.1%, and 9.4% in years 1, 2, and 3, respectively, among oral pharmacological OAB treatments that included generic and branded antimuscarinics: oxybutynin, tolterodine, trospium, darifenacin, fesoterodine, and solifenacin. For a 1 million-member U.S. commercial payer plan, the total prescription costs increased, and the total medical costs decreased during the 3-year time horizon, yielding increases of $0.005, $0.016, and $0.031 from current per member per month (PMPM) costs and $0.90, $2.92, and $5.53 from current per treated member per month (PTMPM) costs, an average of less than 2% of current OAB treatment costs. For the Medicare Advantage plan, the resulting incremental PMPM costs were $0.010, $0.034, and $0.065, and the incremental PTMPM costs were $0.93, $3.04, and $5.76; all were less than 4% of the current cost. The secondary analysis estimated the budgetary effects of reducing the untreated population by 1% annually by initiating treatment with mirabegron. For a commercial payer, this resulted in PMPM cost increases of $0.156, $0.311, and $0.467 from the current value, while the incremental PTMPM cost increased by $6.17, $11.67, and $16.61. For the Medicare Advantage plan, the incremental increases in PMPM costs were $0.277, $0.553, and $0.830, and in PTMPM costs were $6.42, $12.15, and $17.29. Clinically, treating more OAB patients resulted in fewer OAB-related comorbidities from both health plan perspectives, since most events associated with nontreatment could be avoided. In the Medicare Advantage population of the secondary analysis, the total numbers of avoided events were predicted as 452 UTIs, 2,598 depression diagnoses, and 3,020 skin rashes during the time horizon of the model. CONCLUSIONS: Mirabegron addresses an unmet need for therapy for certain OAB patients, for whom antimuscarinics are not recommended because of a risk of cognitive impairment and who are intolerant to the anticholinergic AEs. Using mirabegron involves moderate additional economic cost to a commercial or Medicare Advantage health plan for which medical cost savings can offset a substantial part of increased pharmacy costs. DISCLOSURES: Funding for this study was provided by Astellas. Perk, Wielage, T. Klein, and R. Klein are employed by Medical Decision Modeling, a contract research company that was paid to perform the described outcomes research and build the model contained in this study. Campbell and Perkins are employed by the Regenstrief Institute, which conducted a database analysis for this research. Campbell reports consultancy fees from Astellas, as well as pending grants from Merck, Sharpe, and Dohme Corp. Posta, Yuran, and Ng are employed by Astellas Pharma Global Development, the developer of mirabegron. Study concept and design were contributed by Perk, Wielage, R. Klein, and Ng. Campbell, T. Klein, and Perkins took the lead in data collection, assisted by Perk, Wielage, and Ng. Data interpretation was performed by Posta and Yuran, along with Perk, Wielage, R. Klein, Ng, Campbell, and Perkins. The manuscript was written by Perk and R. Klein, along with Wielage, T. Klein, Posta, Yuran, and Ng, and revised by all the authors.

Somatic Comorbidity in Women with Overactive Bladder Syndrome.

PURPOSE: We explore the influence of co-occurring somatic illnesses on prevalent overactive bladder in women of premenopausal age. MATERIALS AND METHODS: Data for the present study were derived from a nationwide survey on complex diseases among all twins in the Swedish Twin Registry born 1959 to 1985. The present study was limited to female twins participating in the survey (12,850). Generalized estimating equations were used to estimate odds ratios with 95% CIs. Environmental and genetic influences were assessed in co-twin control analysis. RESULTS: Generalized estimating equations analysis showed a significant association between overactive bladder and migraine (OR 1.34, 95% CI 1.15-1.57), fibromyalgia (1.83, 1.54-2.18), chronic fatigue (1.81, 1.49-2.19) and eating disorders (1.56, 1.24-1.96). There was also a significant association with allergic disorders including asthma (1.24, 1.01-1.52) and eczema (1.22, 1.04-1.43). Among reproductive disorders, urinary tract infections (1.60, 1.40-1.84), dysmenorrhea (1.53, 1.33-1.76) and pelvic pain (1.60, 1.31-1.94) showed the strongest association with overactive bladder. Results from co-twin control analysis indicated that the significant associations observed in generalized estimating equations analysis were influenced by environmental and genetic factors without a common pathway model. CONCLUSIONS: Our results suggest a multifactorial and complex pathogenesis of overactive bladder in which associations between various somatic illnesses and overactive bladder may be affected by environmental and genetic factors.

[Overactive bladder syndrome--a public health challenge]. / Syndrome de la vessie hyperactive chez la femme: un défi de santé publique.

Overactive bladder is a highly prevalent clinical syndrome affecting up to 17% of women. It is often associated with urodynamic detrusor overactivity, leads to embarrassment and is frequently under-diagnosed and insufficiently treated. Its pathophysiology is complex and the numerous treatment modalities, some of them of poor evidence, aim to improve quality of life. When physiotherapy fails, anticholinergics are recommended as first-line medical treatment. They can be combined with or replaced by beta3-adrenergic agonists whereas sacral neuromodulation or posterior tibia nerve stimulation are considered an efficient alternative. Addidtionally, cystoscopic injection of botulinum toxine in the bladder has recently been validated in Switzerland as a treatment option for idiopathic overactive bladder.

Transcutaneous parasacral electrical stimulation vs oxybutynin for the treatment of overactive bladder in children: a randomized clinical trial.

PURPOSE: We determined the effectiveness of 2 methods to treat overactive bladder in children using intragroup and intergroup comparisons in a randomized clinical trial. MATERIALS AND METHODS: Nine boys and 19 girls with a mean ± SD age of 6.4 ± 2.18 years were randomly divided into group 1-parasacral transcutaneous electrical stimulation with placebo drug and group 2-oxybutynin with sham scapular electrical therapy. Success was assessed by 1) the rate of complete symptom resolution, 2) a visual analog scale of 0 to 10, 3) the dysfunctional voiding score system, 4) voiding diary records, 5) Rome III criteria and 6) side effect frequency in each group. RESULTS: A total of 13 and 15 patients were randomized to groups 1 and 2, respectively. Symptoms completely resolved in 6 patients in group 1 (46%) and 3 in group 2 (20%) (p = 0.204). A statistically significant improvement was found in the 2 groups in the dysfunctional voiding score system and voiding diary records. However, no statistically significant difference was found between the groups in the visual analog scale score, voiding frequency, and maximum and mean voided volume (p = 0.295, 0.098, 0.538 and 0.650, respectively). Constipation improved in 100% of group 1 patients but in only 55% in group 2 (p = 0.031 vs 0.073). Group 1 showed no side effects while dry mouth, hyperthermia and hyperemia developed in 58%, 25% and 50% of group 2 patients (p = 0.002, 0.096 and 0.005, respectively). Treatment was discontinued by 13.3% of patients in group 2. CONCLUSIONS: Parasacral transcutaneous electrical stimulation was as effective as oxybutynin to treat overactive bladder in children. However, transcutaneous parasacral electrical stimulation was more effective against constipation and showed no detectable side effects. Oxybutynin was more effective for decreasing voiding frequency.

The cost-effectiveness of sacral nerve stimulation (SNS) for the treatment of idiopathic medically refractory overactive bladder (wet) in the UK.

OBJECTIVE: To estimate the long-term cost-effectiveness of specialised treatment options for medically refractory idiopathic overactive bladder (OAB) wet. PATIENTS AND METHODS: The cost-effectiveness of competing treatment options for patients with medically refractory idiopathic OAB wet was estimated from the perspective of the National Health Service in the UK. We compared sacral nerve stimulation (SNS) with percutaneous nerve evaluation (PNE) or tined-lead evaluation (TLE) with optimal medical therapy (OMT), botulinum toxin type A (BoNT-A) injections, and percutaneous tibial nerve stimulation (PTNS). We used a Markov model with a 10-year time horizon for all treatment options with the exception of PTNS, which has a time horizon of 5 years. Costs and effects (measured as quality-adjusted life years) were calculated to derive incremental cost-effectiveness ratios (ICERs). Direct medical resources included are: device and drug acquisition costs, pre-procedure and procedure costs, and the cost of managing adverse events. Deterministic sensitivity analyses were performed to test robustness of results. RESULTS: At 5 years, SNS (PNE or TLE) was more effective and less costly than PTNS. Compared with OMT at 10 years, SNS (PNE or TLE) was more costly and more effective, and compared with BoNT-A, SNS PNE was less costly and more effective, and SNS TLE was more costly and more effective. Decreasing the BoNT-A dose from 150 to 100 IU marginally increased the 10 year ICERs for SNS TLE and PNE (SNS PNE was no longer dominant). However, both SNS options remained cost-effective. CONCLUSION: In the management of patients with idiopathic OAB wet, the results of this cost-utility analysis favours SNS (PNE or TLE) over PTNS or OMT, and the most efficient treatment strategy is SNS PNE over BoNT-A over a 10-year period.

Long term safety of sacral nerve modulation in medicare beneficiaries.

AIMS: Sacral nerve stimulation (SNS) is FDA approved as second-line therapy for both urinary and bowel control. However, there is limited evidence regarding long term safety. We determined adverse events associated with SNS among Medicare beneficiaries. METHODS: We used the 5% national random sample of Medicare claims for 2001-2011 to identify patients. Patients who underwent SNS implantation were identified with Current Procedure Terminology (CPT-4) codes. We determined safety of SNS using analysis of complication occurrences on day of surgery and during 5 years following initial procedure. SAS v9.3 statistical package was used. RESULTS: One thousand four hundred seventy-four patients underwent treatment with SNS in the 5% national sample of Medicare patients within the time period. Representative of real-world patients undergoing SNS surgery, comorbidities included hypertension (69.3%), diabetes (29.4%), chronic pulmonary disease (25.5%), hypothyroidism (25.2%), and depression (22.7%). Few complications occurred on day of surgery. At 90 days, 3.2% of patients had bowel complications, 2.0% urological, 9.4% infectious, and 1.5% stroke. Overall, bowel, neurological health event occurrences were consistent with prior year rates, while infectious events decreased. Of 206 patients who were followed for at least 5 years, 17.3% had devices removed and 11.3% replaced, with 26.1% having at least one of those, leaving 73.9% with original devices. CONCLUSIONS: Urological, infectious, and bowel complication occurrences were low after SNS among Medicare beneficiaries with multiple comorbidities. There were infrequent serious complications like hemorrhage and stroke postoperatively. Although SNS appears safe in this high-risk population, a comprehensive registry will ensure continuous safety.

Risk factors of nocturia (two or more voids per night) in Chinese people older than 40 years.

AIMS: To explore the risk factors of nocturia in Chinese inhabitants aged ≥40 years. METHODS: A randomized, community-based, cross-sectional study was performed on 10,160 inhabitants ≥40 years old in mainland China, via a stratified sampling approach. A questionnaire, including socio-demographics, lifestyle factors and medical history, was completed. Nocturia was defined as a threshold of two or more voids per night. Differences in prevalence between age and gender groups were ascertained by the chi-squared test. Gender-related factors were evaluated by multivariate logistic regression analysis. P < 0.05 was considered to be statistically significant. RESULTS: Data on 9,637 (94.9%) people aged 59.6 ± 9.7 years qualified for final statistical analysis. The overall prevalence of nocturia was 31.7% (3,053/9,637), and this increased with age (P < 0.001). Nocturia was significantly associated with cardiovascular disease and overactive bladder symptom score (OABSS) (P < 0.05), while sporting activities were protective (P < 0.001). Diabetes mellitus (DM) was significantly correlated with nocturia in men (P < 0.05), whereas hypertension was correlated with nocturia in women (P < 0.05). No correlation was found between nocturia and education level, occupation, civil status, tea consumption, body mass index (BMI), female birth history, and International Prostate Symptom Score. CONCLUSIONS: In Chinese people aged ≥40 years, nocturia is associated with aging, OABSS, cardiovascular disease, hypertension, and DM. Sporting activities are negatively associated with nocturia.